Dexamethasone with or without misoprostol to help start labor at term

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, controlled early phase 1 trial at Cairo University Hospital enrolls nulliparous women at or beyond 39 weeks with a singleton, vertex pregnancy who are eligible for induction. Participants are randomly assigned to one of three groups: a single intramuscular 8 mg dose of dexamethasone, vaginal misoprostol 25 μg every 6 hours (up to four doses), or dexamethasone given with the first misoprostol dose. The primary outcome is time from initiation of induction to the beginning of the active phase of labor, with secondary outcomes including duration of active labor, second stage length, mode of delivery, and fetal outcomes. Clinical assessment includes Bishop score, fetal biophysical profile, and inpatient monitoring during induction as per protocol.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age \> 18 years.
* Nulliparous.
* Vertex presentation.
* Singleton pregnancy.
* Gestational age ≥ 39 weeks according to a reliable date for the last menstrual period or a first-trimester ultrasound evaluation.
* No contraindication for vaginal delivery.

Exclusion Criteria:

* Indication for cesarean section e. g. Placenta previa, intrauterine growth retardation, non-vertex presentation and previous cesarean section.
* Maternal medical disorders as diabetes mellitus and severe pre-eclampsia.
* Preterm labour and preterm rupture of membranes.
* Gestational age \<39 weeks of gestation.
* Fetal macrosomia \> 4kg (estimated by u/s).

Where it's running

• Cairo University Hospital (Kasr Al Ainy)
  Cairo, Manial, Egypt Recruiting

Study contacts

• Study coordinator: Abdelfatah M Eldesouky, MD, MRCOG
• Email: a.f.dessouki@gmail.com
• Phone: 00201003370784

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.